Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors

Early Childhood Caries Clinical Trial

Official title:

Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05838469
• Other study ID #: HUDHF-StripCrown
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: August 2024

Study information

• Verified date: April 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the clinical success of modified celluloid strip crown restorations applied using interim therapeutic restoration and high-viscosity glass ionomer cement to the maxillary anterior teeth of children with early childhood caries and cooperation problems.

Description:

Following the decision on the appropriate size of celluloid strip crown, the tooth will be isolated using roll cottons and the "cavity conditioner" (GC, Japan) will be applied to all surfaces for 10 seconds, washed away and dried with cotton pellets. The selected celluloid strip crown will be filled with a fluoride-releasing bulk fill hybrid glass ionomer cement (EQUIA Forte, GC, Japan) prepared by mixing for 10 seconds in an automatic mixer and placed on the tooth with light pressure. The excess material on the crown margins will be removed with a hand instrument, and the celluloid strip crown will be removed from the tooth. If necessary, the restoration will be polished using a polishing discs. After the crown surface is washed and dried, a nano-filled surface sealant (EQUIA Forte Coat, GC, Tokyo, Japan) will be applied for 10 seconds with a micro-tipped applicator and light cured for 20 seconds. Clinical evaluations will be done at the 3rd, 6th and 12th months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• Read the informed consent form and agree to participate in the study
• Healthy children, aged 2-6 years
• Presenting at least one primary anterior tooth with a class I, II, IV or V caries lesion

Exclusion Criteria:

• Uncooperative children
• The need for vital or non-vital endodontic treatment in the primary tooth to be treated
• Previously restorated tooth
• Presence of bruxism, Class III occlusion or deep bite

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Other:
• Pediatric Strip Crown and High Viscosity Glass Ionomer Cement
Following the decision on the appropriate size of celluloid strip crown, the tooth will be isolated using roll cottons and the "cavity conditioner" (GC, Japan) will be applied to all surfaces for 10 seconds, washed away and dried with cotton pellets. The selected celluloid strip crown will be filled with a fluoride-releasing bulk fill hybrid glass ionomer cement (EQUIA Forte, GC, Japan) prepared by mixing for 10 seconds in an automatic mixer and placed on the tooth with light pressure. The excess material on the crown margins will be removed with a hand instrument, and the celluloid strip crown will be removed from the tooth. If necessary, the restoration will be polished using a polishing discs. After the crown surface is washed and dried, a nano-filled surface sealant (EQUIA Forte Coat, GC, Tokyo, Japan) will be applied for 10 seconds with a micro-tipped applicator and light cured for 20 seconds.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Friedl K, Hiller KA, Friedl KH. Clinical performance of a new glass ionomer based restoration system: a retrospective cohort study. Dent Mater. 2011 Oct;27(10):1031-7. doi: 10.1016/j.dental.2011.07.004. Epub 2011 Aug 15. — View Citation

Policy on Early Childhood Caries (ECC): Unique Challenges and Treatment Options. Pediatr Dent. 2016 Oct;38(6):55-56. No abstract available. — View Citation

Policy on Interim Therapeutic Restorations (ITR). Pediatr Dent. 2018 Oct 15;40(6):58-59. No abstract available. — View Citation

Waggoner WF. Restoring primary anterior teeth: updated for 2014. Pediatr Dent. 2015 Mar-Apr;37(2):163-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 12 months regarding "Anatomic form"	alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does	baseline, 3-month, 6-month,12-month
Primary	Change from baseline to 12 months regarding "Marginal adaptation"	alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin bravo: The general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does	baseline, 3-month, 6-month,12-month
Primary	Change from baseline to 12 months regarding "Surface roughness"	alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects	baseline, 3-month, 6-month,12-month
Primary	Change from baseline to 12 months regarding "Marginal staining"	alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin	baseline, 3-month, 6-month,12-month
Primary	Change from baseline to 12 months regarding "Retention"	alpha: intact bravo: chipped/loss of material charlie: complete loss of crown	baseline, 3-month, 6-month,12-month
Primary	Change from baseline to 12 months regarding "Incisal wear"	alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure	baseline, 3-month, 6-month,12-month